The business case for vaccine and drug manufacturing in middle-income countries
Authors: Lenias Hwenda
Journal: The Lancet Global Health (2022)

How does one build a critical mass of evidence around a medical business case opposed by powerful forces with little evidence to build on? The answer is one study at a time. In The Lancet Global Health, Marco Schäferhoff and colleagues1Schäferhoff M Zimmerman A Diab MM et al.Investing in late-stage clinical trial and manufacturing of product candidates for five major infectious diseases: a modelling study of the benefits and cost of investment in three middle-income countries.Lancet Glob Health. 2022; 10: e1045-e1052Summary Full Text Full Text PDF PubMed Scopus (1) Google Scholar address a critical gap in evidence relating to the business case for investing in vaccine and therapeutics manufacturing in three middle-income countries, namely South Africa, Kenya, and India. The study focuses on five infectious diseases: HIV, tuberculosis, malaria, pneumonia, and diarrhoeal diseases. The authors modelled the health and economic benefits of investing in late-stage clinical trial capacity, trial regulatory systems, and local manufacturing capacity over a 16-year period between 2021 and 2036. They estimate that the investments needed range from US$1·5 billion in Kenya and India to $1·7 billion in South Africa. However, such investment in Kenya alone could avert 4·44 million deaths and 206·27 million disability-adjusted life-years (DALYs) in countries belonging to the Common Market for Eastern and Southern Africa region. In South Africa, it could prevent 5·19 million deaths and 253·83 million DALYs in the Southern African Development Community region. In India, it could avert 9·76 million deaths and 374·42 million DALYs in south Asia. This is an important study in the field of vaccine manufacturing for which analyses and evidence from low-income and middle-income countries are scarce or even non-existent. Vaccine manufacturing has long been dominated by a high-income-country perspective that distorts the evidence—by analysing the data in a biased way and omitting relevant factors, such as the aggregate market size and the market dynamics—and has long dismissed the merits of manufacturing medical products outside established manufacturing hubs. In the context of the severe shortcomings of the existing global manufacturing infrastructure in meeting everyone's health needs during the COVID-19 pandemic, Schäferhoff and colleagues' analysis is timely and of tremendous importance. Global pharmaceutical supply chains have repeatedly proved incapable of serving people in all regions of the world in a timely manner that would prevent needless loss of life. During the COVID-19 pandemic, 1·3 billion people living in Africa were not factored into pharmaceutical companies' global supply planning. The African Union attempted to negotiate purchasing agreements with manufacturers, but because manufacturers had no additional stocks that African countries could buy, financing mechanisms established by the regional development banks, such as the African Development Bank and the Africa Export Import Bank, were unable to serve their purpose. Production capacity was not the issue because several countries could buy vaccine stocks far exceeding their national needs. Hoarding, which has been a characteristic of every pandemic in recent history, was the problem. Millions of the excess doses would subsequently expire while billions of people went unvaccinated. Therefore, compelling low-income and middle-income countries to rely on donations of vaccines, often nearing expiry, is unethical. It is also untenable that a region such as Africa, with 17% of the global population and 25% of the global burden of disease, imports 99% of its vaccine needs and 95% of its medicine needs. After all, as historical precedence has shown multiple times, governments will always seek to meet their own electorates' needs first, leaving regions with negligible production capacity with no vaccine purchasing options. It is therefore time to abandon the fallacy of global solidarity, the empty promise of multilateralism, and the rarely fulfilled donation pledges. All have repeatedly proven impractical. A more practical approach is globally distributed manufacturing operations serving different regions of the world, underpinned by effective clinical research ecosystems. Too few clinical trials are done in low-income and middle-income countries. Africa alone accounts for less than 3% of clinical trials globally.2Duermeijer C Amir M Schoombee L Africa generates less than 1% of the world's research; data analytics can change that. Elsevier Connects.https://www.elsevier.com/connect/africa-generates-less-than-1-of-the-worlds-research-data-analytics-can-change-thatDate: March, 2018Date accessed: May 20, 2022Google Scholar Investing in trials is crucial to improve the availability of relevant data to support clinical guidelines for populations in these countries. Schäferhoff and colleagues make a compelling case for investing in late-stage clinical trials, clinical regulatory systems, and local manufacturing. However, lack of previous empirical evidence meant that the authors relied on many assumptions. Most of these assumptions reflect the reality on the ground—eg, the assumption that only one trial could be conducted per site at any given time. However, some, such as the extent to which donors bear the burden of health financing, suggest that the authors lack familiarity with the national contexts of their study. Donors rarely bear the entire costs, especially in middle-income countries such as South Africa, Kenya, and India, which are reducing donor support towards their traditional vaccine needs. Nevertheless, the authors' investment case from a regional market perspective reflects the normative approach to evaluating Africa's high-volume market. Cumulatively, studies like this will strengthen the evidence base needed to inform decision making by investors in vaccine manufacturing, the African Medicines Agency, and clinical research. I declare no competing interests. Investing in late-stage clinical trials and manufacturing of product candidates for five major infectious diseases: a modelling study of the benefits and costs of investment in three middle-income countriesOur study supports the creation of regional hubs for clinical trials and product manufacturing compared with narrow national efforts. Full-Text PDF Open Access